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Evaluation of the Safety and Tolerability of Gemini in Subjects With Stage 3-4 Chronic Kidney Disease.

NCT06863467 · Status: COMPLETED · Phase: PHASE1/PHASE2 · Type: INTERVENTIONAL · Enrollment: 40

Last updated 2025-10-29

No results posted yet for this study

Summary

Gemini is being evaluated in a placebo controlled, single dose, escalating dose study to evaluate the safety and tolerability of intravenous Gemini in adult subjects with stage 3 or 4 chronic kidney disease. Pharmacokinetics will be evaluated and measurements of the effect of Gemini on pharmacodynamic activity will be measured to assess changes in potential pharmacodynamic markers.

Conditions

  • Renal Insufficiency, Chronic
  • Chronic Kidney Disease stage3
  • Chronic Kidney Disease stage4

Interventions

DRUG

Intravenous Gemini

Single ascending intravenous dose infused once over 10-15 minutes.

DRUG

Intravenous placebo

Intravenous sugar solution infused in a single dose over 10-15 minutes.

Sponsors & Collaborators

  • Revelation Biosciences, Inc

    lead INDUSTRY

Principal Investigators

  • Chief Executive Officer · Revelation Biosciences, Inc

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
SEQUENTIAL

Eligibility

Min Age
18 Years
Max Age
80 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2025-01-20
Primary Completion
2025-07-22
Completion
2025-07-22
FDA Drug
Yes

Countries

  • United States

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT06863467 on ClinicalTrials.gov